关键词: 雅培 AbbVie 药物召回
2013年1月14日讯 /生物谷BIOON/ --上市不足3周,AbbVie宣布首次药物召回。AbbVie称,此次行动已召回超过28500瓶甲状腺药物Synthroid(合成甲状腺素),原因是在一个批次的一瓶Synthroid(150mcg片剂)中发现了低剂量(75mcg)片剂,AbbVie发言人Gregory Miley称,此次药片混淆是由一条生产线的清理故障所致。(生物谷bioon.com)
英文原文:Less than three weeks old, and AbbVie ($ABBV) has announced its first recall. The company said it recently pulled more than 28,500 bottles of the thyroid drug Synthroid because of a tablet mix-up. As The Wall Street Journal reports, it's the second Synthroid recall in 6 months.
The recall applies to one lot of 150-mcg tablets. Tablets of the lower 75-mcg dosage were found in one bottle in that lot. AbbVie spokesman Gregory Miley told the WSJ that the tablets were misplaced because of a clearance error on one manufacturing line.
The mix-up and resulting recall happened before AbbVie entered 2013 as a newly independent company, having been spun off from Abbott Laboratories ($ABT). It follows a July recall--involving three lots of the drug--that was caused by defective bottles that might have shortened the drug's shelf life. More than 136,500 bottles were involved, but most of them had not yet shipped, the company said.
Other drugmakers have been caught by line-clearance errors. Novartis ($NVS) had to pull drugs made at its Lincoln, NE, consumer health plant after some bottles were found to contain the wrong drugs and others contained broken tablets.